Education and Advocacy Track:A Consensus Roadmap to Curb
Deaths from Rx Drug Misuse and Abuse in the U.S.
Presenters:
• Shannon Frattaroli, PhD, MPH, Associate Professor of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, and Associate Director for Outreach, Center for Injury Research and Policy
• Andrew Kolodny, MD, Chief Medical Officer, Phoenix House Foundation, Inc., and Director of Physicians for Responsible Opioid Prescribing
• Alexander Chan, MPA, MCM, Associate Director of National Strategy, Clinton Health Matters Initiative
• Alex Cahana, MD, Professor in Pain Medicine and Bioethics, University of Washington
Moderator: Nancy Hale, President and CEO, Operation UNITE
Disclosures
Shannon Frattaroli, PhD, MPH; Andrew Kolodny, MD; Alexander Chan, MPA, MCM; Alex Cahana, MD; and Nancy Hale have disclosed no relevant, real, or apparent personal or professional financial relationships with proprietary entities that produce healthcare goods and services.
Disclosures
• All planners/managers hereby state that they or their spouse/life partner do not have any financial relationships or relationships to products or devices with any commercial interest related to the content of this activity of any amount during the past 12 months.
• The following planners/managers have the following to disclose:– Kelly Clark – Employment: Publicis Touchpoint Solutions;
Consultant: Grunenthal US– Robert DuPont – Employment: Bensinger, DuPont &
Associates-Prescription Drug Research Center– Carla Saunders – Speaker’s bureau: Abbott Nutrition
Learning Objectives
1. Research the Clinton Foundation’s national, cross-disciplinary team charged with identifying Rx drug abuse strategies.
2. Outline the team’s recommendations for strategies to reverse alarming trends in opioid related injuries and deaths.
A Consensus Roadmap to Curb Deaths from Prescription Drug Misuse and
Abuse in the United States
Context of Our Initiative
Community-based Prevention Strategies
Shannon Frattaroli, PhD, MPHThe Johns Hopkins Bloomberg School of Public Health Center for Injury Research and Policy
Disclosure
• Shannon Frattaroli, PhD, MPH, has disclosed no relevant, real, or apparent personal or professional financial relationships with proprietary entities that produce healthcare goods and services.
Consensus Roadmap Background
• Johns Hopkins Bloomberg School of Public Health and the Clinton Health Matters Initiative
• Identifying Experts
• Town Hall
• Expert Meeting
• Post-Meeting Commitments
Consensus Roadmap Working Groups
• Engineering strategies: Rx drugs and packaging
• Prescribing guidelines
• Prescription drug monitoring programs
• Naloxone distribution
• Community-based prevention strategies
• Addiction treatment
• PBMs and Pharmacies
Working Groups’ Charge
• Draft a Report
– Statement of the Problem
– Synthesis of Available Evidence
– Recommendations for Action
– Communications Recommendations
Plan for the Consensus Roadmap
• Annual Event
• Report Release
• Engagement with New Stakeholders
• Dissemination Strategy
• Next Steps
Community-based Prevention Strategies
• Statement of the Problem
– There is no organized community approach to primary prevention of OPR misuse and abuse
Community-based Prevention Strategies
• Synthesis of Available Evidence
– OPRs: Activity vs. Evidence• Harm reduction• Prevention
– Lessons from Other Topics • Antibiotic use and children• Alcohol• Other substances
Community-based Prevention Strategies
• Recommendations for Action: Focus on Specific Populations
– School Children
– College Students
– Substance Users
– Acute Pain Patients
– Chronic Pain Patients
– General Public
Community-based Prevention Strategies
• Communications Recommendations
– Funders and the need for evaluations of community-based interventions
– Varied stakeholders and the need for storage and disposal interventions
– Policymakers (legislative and executive) at the state and local levels and opportunities for leadership on this issue
Responding to North America’s
Opioid Addiction Epidemic
Andrew Kolodny, M.D.Chief Medical Officer, Phoenix House Foundation Inc.Executive Director, Physicians for Responsible Opioid PrescribingSenior Scientist, Heller School for Social Policy and Management, Brandeis UniversityResearch Professor, Global Institute of Public Health, New York University
Disclosures
• Andrew Kolodny, MD, has disclosed no relevant, real, or apparent personal or professional financial relationships with proprietary entities that produce healthcare goods and services.
How the opioid lobby frames the the Rx problem
Source: Slide presented by Lynn R. Webster MD at FDA meeting on hydrocodone upscheduling, January 25th, 2013.
Pain Patients “Drug Abusers”
63% admitted to using opioids for
purposes other than pain1
35% met DSM V criteria for
addiction2
1. Fleming MF, Balousek SL, Klessig CL, Mundt MP, Brown DD. Substance Use Disorders in a Primary Care Sample Receiving
Daily Opioid Therapy. J Pain 2007;8:573-582.
2. Boscarino JA, Rukstalis MR, Hoffman SN, et al. Prevalence of prescription opioid-use disorder among chronic pain patients:
comparison of the DSM-5 vs. DSM-4 diagnostic criteria. J Addict Dis. 2011;30:185-194.
This is a false dichotomy
92% of opioid OD decedents
were prescribed opioids for
chronic pain.
3. Johnson EM, Lanier WA, Merrill RM, et al. Unintentional Prescription Opioid-Related Overdose Deaths: Description of
Decedents by Next of Kin or Best Contact, Utah, 2008-2009. J Gen Intern Med. 2012 Oct 16.
21
Source: Kolodny et al. The Prescription Opioid and Heroin Crisis: A Public Health Approach to an Epidemic of Addiction. AnnuRev Public Health. 2015: 36:559-574
Non-medical use (abuse) of painkillers declining since 2002
22
Source: Kolodny et al. The Prescription Opioid and Heroin Crisis: A Public Health Approach to an Epidemic of Addiction. Annu Rev Public Health. 2015: 36:559-574
Non-medical Opioid Users Opioid Overdose Decedents
23
Death rates from overdoses of heroin or prescription opioid pain relievers (OPRs), by age group
SOURCE: CDC. Increases in Heroin Overdose Deaths — 28 States, 2010 to 2012 MMWR. 2014, 63:849-854
0
2,000
4,000
6,000
8,000
10,000
12,000
14,000
16,000
18,000
20,000
22,000
24,000
26,000
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013
Painkillers Heroin Total Opioid
Year
Opioid Related Overdose Deaths
United States, 1999-2013
Source: CDC National Center for Health Statistics
Primary non-heroin opiates/synthetics admission rates, by State(per 100,000 population aged 12 and over)
26
Primary non-heroin opiates/synthetics admission rates, by State(per 100,000 population aged 12 and over)
27
Primary non-heroin opiates/synthetics admission rates, by State(per 100,000 population aged 12 and over)
28
Primary non-heroin opiates/synthetics admission rates, by State(per 100,000 population aged 12 and over)
29
Primary non-heroin opiates/synthetics admission rates, by State(per 100,000 population aged 12 and over)
30
Primary non-heroin opiates/synthetics admission rates, by State(per 100,000 population aged 12 and over)
31
Controlling the epidemic:A Three-pronged Approach
• Prevent new cases of opioid addiction
• Treatment for people who are already addicted
• Supply control- Efforts to reduce over-prescribing and black-market availability
32
Opioid Addiction Treatment
• Psychosocial Approaches
– 12 Step
– Residential
– Cognitive Behavioral Therapy
• Pharmacological Approaches
– Buprenorphine
– Methadone
– Naltrexone
Buprenorphine Experience in France
• Introduced in the mid 90s
• 80% decline in OD deaths in 6 years*
• Associated with diversion and injection use
*Emmanuelli J, Desenclos JC. Harm reduction interventions, behaviours and associated health outcomes in France, 1996–2003. Addiction 2005;100:1690–1700.
Retention in TreatmentKakko, Lancet 2003
Treatment duration (days)
Rem
ain
ing in t
reatm
ent
(nr)
0
5
10
15
20
0 50 100 150 200 250 300 350
Detoxification
Maintenance
Buprenorphine RCT A Tragic Appendix: Mortality
Kakko, Lancet 2003
Placebo BPN
Dead 4/20 (20%) 0/20 (0%)
Barriers to Buprenorphine
• Ideological
• Federally imposed patient caps
• Federally imposed ban on NP and PA prescribing
• Addiction stigma limiting integration in primary care
• Inertia
Summary
• The U.S. is in the midst of a severe epidemic of opioid addiction
• To bring the epidemic to an end:
– We must prevent new cases of opioid addiction
– We must ensure access to treatment for people already addicted
A Consensus Roadmap to Curb Deaths from Prescription Drug Misuse
and Abuse in the United States
Scaling Access to Naloxone in Communities of Need
Alex Chan has no disclosed relevant, real or apparent personal or
professional financial relationships with proprietary entities that produce
health care goods and services.
Disclosures
The Clinton Foundation helps transform lives and
communities from what they are today to what they can
be by creating partnerships of great purpose to deliver
sustainable solutions and empower people to live better
lives.
Clinton Foundation Purpose & Approach
Clinton Health Matters Initiative
What We Do
• Build strategic partnerships that will help facilitate the development and scaling of health promoting solutions.
• Work across sectors to develop and implement coordinated, systemic approaches to creating healthier communities.
• Leverage technology and digital innovation to help advance health and wellness at the national and community levels by disseminating evidence-based individual, systems, and investment strategies.
Prescription Drug Abuse & Misuse
Goal: The Clinton Foundation seeks to cut prescription drug abuse deaths in half – saving approximately 10,000 lives – through strategic
partnerships that raise consumer and public awareness, advance business practice change, and
mobilize communities.
The Campus Program
Johns Hopkins
Partnership
Scaling Access to Naloxone
Why Naloxone?
1. In the US in 2010, opioid analgesics, such as oxycodone, hydrocodone, and methadone, were involved in about 3 of every 4 pharmaceutical overdose deaths (CDC, 2013).
2. Most prescription opioid deaths occur outside of medical settings (Paulozzi , 2012).
3. The number of community-based overdose education and naloxone distribution (OEND) programs has been on the rise; at least 188 community-based programs were in existence in the US in 2010 (Wheeler, Davidson, Jones, & Irwin, 2012).
4. Data from a 2010 survey found that 48 OEND programs in the US had trained and provided naloxone to over 50,000 individuals between 1996 and 2010, and reported over 10,000 opioid overdose reversals during this time (Ibid) .
Starting Points
•April 2014•25 Cross-sectorial •Identified barriers and
Naloxone Working Group
•May 2014•25 Representatives across
and sectors•Identified common agenda
established 7 key priorities
Johns Hopkins Working Group
Naloxone Purchasing Agreement
s
Barriers to Usage
• Lack of awareness of naloxone across a complex healthcare delivery system
• CMS: Engaging CMS in the conversation
• Role of business • Stigma: as it applies to 1) individuals;
2) community (cultural acceptance); 3) people/ organizations (i.e. law enforcement) that are promoting naloxone access
• Training: Need for professional training; not well defined currently
• Laws: Numerous laws need to be addressed that prevent access
• Lack of Data:• Need for better data to support
different prevention and organizational recommendations
• Need for better data about cost-effectiveness of Naloxone
• Need for data about co-prescribing
• Politics: the different ideologies that are likely to clash
• Lack of unified message• Money: Someone needs to pay for
this; thinking about how other groups might be able to pay
• Affordability • Accessibility of naloxone in the
physical space • Confidentiality: Issue of
confidentiality and the lack of sharing information
• Coverage • Criteria for Use of naloxone • Communication to patients +
individuals
Barriers to Usage: Training
• Integrating Naloxone education into a variety of education programs; certifications; and surveys
• Lack of accessible CME content through different mediums for a variety of groups • How to develop content that
people want to learn • No clear framework on how to get
doctors to “buy-in”• Making Naloxone access a norm ( i.e.
seatbelt : following a road safety norm)
• Messaging ( i.e. how to position this as a universal precaution) • How to translate this technical
space into something that is engaging
• Putting message into untraditional + “edgy” forms
• Org taking Leadership role: Who is taking the leadership role? What is their responsibility?
• Education: Educating patients on how to educate caregivers
• Lack of awareness in understanding overdose
• CME: Time, interest and incentive to schedule this into your CME
• Training: Time, interest and incentive to create broader training; Integrating training into the collective bargaining process
• Antiquated training system • Lack a standard of delivery• Workforce: No workforce for
disseminating this information • Government providing advice and
guidance and developing medical boards
• Lack of understanding of medical legal standard of care
• Figure out ways to work with state and national boards
Barriers to Usage: Community Access
• Developing syringe exchange framework
• Catalyzing parent involvement• Risk of overdose is more privatized• Barriers around the law: what is legal?• Issues of stigma and community
perception• Issue of warm hand-off to treatment • Funding for the community &
coverage • Lack of integration in the healthcare
system ( i.e. education, advocacy) ; how do you make it apart of the whole solution?
• Education between prescription and using Naloxone
• Developing a pharmacy care model; what’s pharmacy’s role?
• Stuck in a prescription model • Mode of delivery; how to make it
more accessible • Shelf life of Naloxone ( awareness) • Complexity of system • Availability and accessibility
What’s Working
• Reversal success is self-perpetuating • Re-define community groups :
success with law enforcement and first responders
• All EMTs (local and rural) will be trained
• Naloxone distribution with education + awareness campaigns through a variety of channels - expanding the definition of gate-keepers to include places such as local schools
• Leadership investment changes what the outcomes are
• Needle exchange programs• Collaborative practice agreements • Professional association expectation• Needing better models on education
(Rhode Island model is very promising)
• Building on the REMS Framework• Developing new aspects to
Prescription Drug Monitoring Programs - incorporate pharmacy benefit managers as well as insurance companies as well
• Create evidence-base and more effective educational messages
• Getting attention of doctors on how it is effecting their patient population
• Developing guidelines on who to prescribe Naloxone to
• Creating new terminology• Improving supply chain • Improving the standard of care• Making it user-friendly• Empowering parents (i.e. moms) to
be heroes and working with families
• Emphasis on prevention (addressing over prescribing), education and awareness
• Building strong community partnerships (i.e. law enforcement)
• Exercise caution when labeling things as “safe”
• Making it widely available through simplicity and accessibility ( i.e. community centers)- Finding ways to meet people
where they are
What Does Success Look Like?
1. Provide a predictably affordable supply of Naloxone to community groups, creating a window of opportunity for the naloxone distribution field to scale over the next four years.
2. Expand digestible and engaging continuing medical education on naloxone targeting doctors, nurses, dentists, pharmacists and others.
3. Accelerate efficient and rigorous implementation of community-based distribution and access efforts.
Negotiated Agreement Experience
• 2002: CHAI negotiates discounts for antiretroviral medicine in Sub-Saharan Africa
• 2004: AHG brokers beverage industry agreement.
• 2006: CHAI and UNITAID expand coverage to pediatric ARV in developing countries
• Ongoing: AHG supports employers who adopt the Healthier Generation Benefit.
Purchasing Agreements & Partnerships
1. Negotiate agreements with manufacturers of all forms of naloxone, including inhalants, injectables, and other forms under development.
2. Determine appropriate pricing mechanism that allows public safety agencies and community based organizations to purchase naloxone at a discount close to federal pricing.
3. Develop purchasing platforms and mechanisms to assist qualified organizations to participate in the discount pricing program.
Initial Target Audiences
1. Campus Program Colleges• 80 Schools• 23 States
2. Public Safety Agencies & Community Based Organizations• Houston, TX• Jacksonville, FL• Little Rock, AR• Coachella Valley, CA• Adams County, MS
A Consensus Roadmap to Curb Deaths from Prescription Drug Misuse and
Abuse in the United States
Legislative and Policy Remedy
The story of WA state
Disclosures
• Alex Cahana, MD, has no disclosed relevant, real or apparent personal or professional financial relationships with proprietary entities that produce health care goods and services.
Approved learning objectives:
• At the end of the session attendees will be able to describe essential elements within policies that positively impact care for patients who are candidates for opioid therapy
• Describe recommendations to improve state policies
AMDG Guidelines
• In response to opioid related deaths in WA
• April 2006 AMDG (Medicaid; worker’s comp; DoCorr; DoH; Public employees) convened
• w/ UW, private practitioners; 5 x 3h meetings
• Consensus Guidelines
• 120mg/d MED yellow flag
• April 2007 educational pilot
Voluntary educational efforts
• 35 Category I CME presentations to primary care
• 2 hour free category I online test
• WSMA endorsement
• AHRQ endorsement
• In 2009, web based survey:
• 45% were familiar and applied guidelines
• 54% who treat pain patient have concerns
• 86% believe 120mg MED is reasonable or too high
ESHB 2876 (2010)
• Repeal WAC 246-919-830 from December 1999
• “no disciplinary action will be taken against a practitioner based solely on the quantity or frequency of opioids prescribed”
ESHB 2876 mandated:
• Use of Opioid dosing criteria (AMDG)
• Guidance on when to seek pain consultation (TeleHealth)
• Guidance on tracking adherent use of opioids (PDMP)
• Guidance on tracking clinical progress focusing on pain interference, mood and function
Other legal remedies:
• ESHB 2127: requiring ED opioid guidelines
• ESHB 1370: Take back medicine programs
• ESHB 5516: Samaritan law
• ESHB 1671: Increased access to Naloxone
• ESHB 1403: Paying for TeleMedicine
Education and Advocacy Track:A Consensus Roadmap to Curb
Deaths from Rx Drug Misuse and Abuse in the U.S.
Presenters:
• Shannon Frattaroli, PhD, MPH, Associate Professor of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, and Associate Director for Outreach, Center for Injury Research and Policy
• Andrew Kolodny, MD, Chief Medical Officer, Phoenix House Foundation, Inc., and Director of Physicians for Responsible Opioid Prescribing
• Alexander Chan, MPA, MCM, Associate Director of National Strategy, Clinton Health Matters Initiative
• Alex Cahana, MD, Professor in Pain Medicine and Bioethics, University of Washington
Moderator: Nancy Hale, President and CEO, Operation UNITE
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